FDA.reportPublic FDA data

BUN Reagent

Primary DI
00811403011124
Brand
BUN Reagent
Company
Diamond Diagnostics Inc.
Model
BK-443350D
Device description
For the quantitative determination of urea nitrogen in serum or plasma.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDSElectrode, Ion Specific, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403011124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403011124008114030111248114030111240811403011124

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403011469Glucose Electrode MembraneBK-670597D2023-06-12
00811403011667Glucose ReagentBK-472500D2023-06-12
00811403011636Glucose ElectrodeBK-469499D2023-06-10
00811403011131Glucose Reagent BK-443355D2023-06-05
00811403011605Albumin ReagentBK-467858D2023-06-10
00811403015504Maintenance KitHM-XEA328ASD2023-06-13
00811403015511O-Ring KitHM-XEA486ORD2023-06-13
00811403018901Vaccuum Pump Rebuild KitCO-67030079D2023-06-13
00811403019045Compressor Rebuild KitSX-28144879D2023-06-13
00811403019052Compressor Rebuild KitSX-44368656D2023-06-13
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+0-DD-SMARTLYTEPLUS2023-06-05
00811403013289Wash PackCD-473497D2023-06-13
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCDS2017-04-24
00385480485968STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2017-04-21
04015630018123cobas b 221 GLU/LAC/UREA (BUN) CassetteRoche Diagnostics GmbHCDS2016-09-24
00856522006033H4 CartridgeLifehealthCDS2016-09-24
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-22
00385480087964NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480176125NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
10385480087961NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131926NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480145756NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480146104NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148306NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148443NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480161534NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480165013NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20